Warning letter
Professional Disposables International, Inc.: warning letter of Jan 7, 2022
FDA warning letter 617201 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 617201 |
|---|---|
| Company | Professional Disposables International, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 7, 2022 |
| Posted date | Jan 18, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.34, 314.81(b)(1), 314.81(b)(1)(i) |
| Inspection city | Orangeburg |
| Inspection ZIP | 10962 |
| Inspection start date | May 5, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: